Method for cancer therapy using herbal extracts

ABSTRACT

A new method is described for the treatment of cancer. In one alternative, the method utilizes two main compositions. The first composition is Soma, a healing herb described in the Rig Veda, the sacred scriptures of the Hindus. The second composition is a composite of plant-derived substances and a mineral. When they are administered to cancer patients following the recommended therapeutic regimen, regression of the cancer results. Alternatively, the second composition can be used alone.

CROSS-REFERENCES

This application is a continuation-in-part of application Ser. No.10/670,131 by Grandics et al., filed on Sep. 22, 2003 now U.S. Pat. No.7,201,924 and entitled “Method for Cancer Therapy Using HerbalExtracts,” which is a continuation-in-part of application Ser. No.10/227,006 (now abandoned), by Peter Grandics, filed on Aug. 23, 2002and entitled “Method for Cancer Therapy Using Herbal Extracts,” which inturn was a continuation-in-part of application Ser. No. 09/949,126 (nowabandoned) by Peter Grandics, filed Sep. 7, 2001, and entitled “Methodfor Cancer Therapy Using Herbal Extracts.” The contents of applicationSer. Nos. 10/670/131, 10/227,006, and 09/949,126 are all incorporatedherein in their entirety by this reference.

BACKGROUND OF THE INVENTION

This invention is directed to herbal compositions for treating cancer asa disease with an inflammatory component and to methods employing thesecompositions.

General Background and State of the Art: It is a widely accepted viewthat cancer can start in just one of the body's billions of cells.Cancer could be triggered by a variety of factors. Our current thinkingis that radiation, toxic chemicals, viruses or other infectious agentsmay induce an error in the transcription of the cell's geneticinformation. The cells then divide to form abnormal cells, withoutnormal genetic controls. The immune system of the body then fails torespond properly by not destroying the aberrant cells. The aberrant(cancerous) cells lose their normal controls of cell division andcontinue to proliferate. This leads to the formation of a growing massor tumor expanding into healthy tissues. The cancerous cells competewith normal cells for nutrition. Also, the cancerous cells may migrateinto the bloodstream or the lymphatic system that is the primary causeof the formation of a metastasis.

It is currently believed that cancer could be reversed if the alteredgenetic message of the cell could be corrected. However, such a methodup to this date has not been developed. Our current mainstream treatmentmethods focus exclusively on the tumor and equate cancer with thecancerous lesion(s) appearing in these patients. This way cancer isconsidered a localized phenomenon that may lead to an incompletedefinition of this disease.

The mainstream treatment modalities for cancer are sometimes describedas the cut, burn and poison therapies. As the cancerous lesion isequated with cancer, its surgical removal, whenever is possible, isconsidered indispensable. This is done despite the evidence that surgeryfails to correct the underlying cause of cancer and may actually causethe spreading of cancer. Residual lesions are treated with radiation andchemotherapy, both of which produce severe side effects. Thesetreatments are immunosuppressive and can pave the way to secondaryinfections, an important cause of mortality following chemotherapy.

Toxicity to the kidneys, bone marrow and the nervous system may producelasting complications even if a remission is achieved. It is alsoestablished that such therapies can actually cause secondary tumors.Regardless of the practice of these cancer treatments, two-thirds of allcancer patients eventually die of the disease. Moreover, many of themalignant tumors are resistant to these conventional treatments.

A safe and effective cancer treatment has been the goal of scientistsfor many decades. Such a technique must be selective in destroying thecancer cells without irreversibly damaging normal cells. It is wellestablished that cancer is continually produced in the human body but iskept in check by the immune system. Only when the immune system isweakened can cancer establish itself. Therefore, it would be desirableto develop methods that restore the healing ability of the body socancer would be eliminated naturally by the immune system.

INVENTION SUMMARY

Pursuant to this invention a new technique is described to treat cancer.In an illustrative embodiment, an inoperable, malignant lung cancer wastreated with a plant extract called Soma, and an adjunct secondtherapeutic modality comprised of a mixture of natural plant derivedsubstances and a mineral. The Soma and the adjunct second therapeuticmodality can be used together; alternatively, the second adjuncttherapeutic modality can be used alone.

Methods according to the present invention are particularly suited tothe treatment of malignancies of the lymphoid system.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Interest in alternative therapies is increasing as dissatisfaction withtraditional therapies grows. The absence of markedly improved treatmentsdespite decades of research, the toxicity of chemotherapy and the lackof significant improvement in cure rates for the major cancerscontribute to the dissatisfaction (Cassileth et al. (1991) New EnglandJournal of Medicine 3249 (17) 1180-1185). This led to an increasinginterest even within the traditional medical community for alternativecancer treatments.

The present invention describes an alternative therapy for cancer. Weoffer a new theory for the development of this disease that describescancer as an endocrine disease. More specifically, we hypothesize thatcancer manifests as a result of the malfunctioning of the pituitarygland that resides at the apex of the endocrine system. Pituitaryhormones regulate the functions of other glands, e.g., the thyroid, theadrenals or the pancreas. A dysfunctional pituitary gland manifests inthe weakening of the immune system and eventually in its inability toeliminate cancerous cells.

This hypothesis proposes that cancers arise from a single cancer“progenitor” cell that gives rise to all known forms of cancer. Thiscell is part of the working mechanism of the immune system and normallyresides in the sinus cavity from which it is mobilized as needed. Thesecells are eliminated by specific activated lymphocytes after theycomplete their tasks. When the elimination of these cells isunsuccessful due to weakened thyroid, adrenal, and pancreaticactivities, viable damaged cells remain that can attack host tissue.These cells will seek out injury sites inside the body that are presentdue to physical damage, the activities of pathogenic organisms,parasites, chemical agents, or irradiation and establish colonies atthose locations. The final morphology of the cancer cells develops as aresult of interactions with the surrounding host tissue.

Secretions of the thyroid and adrenal glands and the pancreas play acritical role in the activation of the killer cell capable ofeliminating cancer “progenitor” cells as well as established tumors.

The described natural formulas are intended to optimize the functioningof the pituitary gland as well as the other three endocrine glandsleading to the restoration of normal immune functions. The effect of theformulas results in the regression of cancerous growth without the sideeffects of contemporary therapies.

A potential causative agent for cancer, besides the environmentalfactors, is prolonged periods of stress. Stress has been found to beassociated with immunosuppression and an increased frequency of tumors(Lissoni, P. et al. Neuroendocrinol. Lett. (2001) 79, 350-357).Therefore, it is important that life-style changes also accompany anytherapeutic intervention if long-term results are sought.

The following compositions are described in the subject invention.

In one embodiment of the invention, two compositions are used.

In this alternative, the first composition is an extract of the Somaplant. Soma is the famous healing plant described in the sacredscriptures of the Hindus, the Rig Veda (Griffith R T H, The hymns of theRigveda, Shastri, J L ed. Delhi, Motilal Banarsidass Publishers, 1999).Since the passing of the Vedic era, many investigator sought to identifythis mystical herb to which religious tradition attributes many greathealing powers.

As a result, today Soma is mainly believed to be the hallucinogenicmushroom, Amanita muscaria. However, Indian scientist Dr. S N Paddhyfrom the Department of Botany, Orissa Government Science Collegechallenged this view and stated that the actual Soma plant was neitherhallucinogenic nor intoxicating, but kept its consumers awake and alert(The Indian Times, Feb. 11, 2001). He pointed out that theidentification of Soma as Amanita muscaria is in conflict with the Vedicprinciples, its reported mode of action, as well as the description ofthe plant in the scriptures. The Soma plant is said to have milkysecretions, a creeper-like appearance, and exists in two varietiesaccording to the Rig Veda. We concur with Dr. Paddhy's analysis on Soma.Accordingly, the botanical identification of the Soma plant is Asclepiastuberosa.

In one alternative, Soma extract was prepared following the generalrecommendations in the 9th Book of Rig Veda with some modifications.More specifically, the root of the mature Soma plant was harvested andcleaned in water. The roots were cut into small pieces and placed in awooden bowl with water added for extraction of the active ingredients.The roots were crushed with a stone pestle while soaked in water. Thecrushed mixture was placed in a glass bottle and allowed to sit for amonth. Salt is added to the mixture as preservative. Subsequently, themixture was filtered to remove insoluble materials. Soma extract isstored refrigerated. Alternatively, Soma extract is commerciallyavailable from A-D Research Foundation (Carlsbad, Calif.).

In a preferred alternative, the minced roots of Asclepias tuberosa aresteeped in boiling water for about 20 minutes to inactivate potentiallytoxic proteins. The roots are filtered and the supernatant is used as atherapeutic.

The other component of this first embodiment of the subject invention isa mixture of plant-derived and mineral substances, called MSQ-11. Morespecifically, the active ingredients are blackstrap molasses, applecider vinegar, quinine, and sulfur. The optimal composition is made upas follows:

Thoroughly mix in a blender the following ingredients in this order:

1. 755 ml blackstrap molasses,

2. 59 ml apple cider vinegar,

3. 3 g quinine (USP grade),

4. 29 g of sulfur (USP grade).

Blend on high speed, and add sufficient whole milk to bring the finalvolume to 1 quart (946 ml). The mixture is stored refrigerated. Forlong-term storage, it must be kept in a freezer. Additional optionalingredients are Vitamin B₁₂ (63 mg), folic acid (250 mg), and rose petalextract/rose oil (50 .mu.l) dissolved in the final quart. One or more ofthese optional ingredients can be used. The formula including VitaminB₁₂ and rose oil is designated MSQ-11A. For milk-intolerant patients,such as patients with lactose intolerance, the milk in the formula canbe replaced by purified water.

In this first embodiment, to treat malignancies of the lymphoid system,the formula is complemented with the following additions and calledMSQ-12.

1. ½ tsp of ground red pepper,

2. 2 tbsp of corn oil,

3. 177 ml of fresh squeezed pineapple juice,

4. 87 g of finely ground raw almonds, and

5. 2 aspirins a day taken separately by the patient.

The MSQ-11 formula can be used on its own if iodine (USP 23, StrongIodine Solution) is added to the composition in the amount of 6-9 ml per1 quart (946 ml) final volume that is equivalent to 4-6 drops per 30 mlsingle dose. This formula is called MSQ-13

In this first embodiment, Soma is taken orally once a day, preferablyone hour before bedtime. The recommended dosage is 1 ml dispersed into acup of water. Soma should be taken for a month at this dosage. For thenext month, it should be taken every other day. A weeklong break in theschedule is then recommended. The dosing is resumed at a rate of 0.5 mlper day for one month and the same dosage taken every other day for thenext month.

In this first embodiment, the composite mixture (MSQ-11, MSQ-12 orMSQ-13) is administered orally at a dose of 1-3 tbsp (15-45 ml) foradults, preferably at 2 tbsp, three times a day taken with meals. Alongwith this treatment, 6 glasses of water should be taken daily spaced atproper intervals. This administration schedule is followed for 3-4weeks. The administration of this therapy may continue depending on therate of cancer regression. The therapy can be used prophylacticallyafter remission is obtained.

When used in conjunction with chemotherapy, Soma has largely relievedchemotherapy-associated nausea and vomiting. Patients taking Soma wereable to carry on with their normal activities shortly after theadministration of the chemotherapeutic agents. In one patient, Soma hasshown some degree of protection against the nephrotoxicity of Cisplatin.Accordingly, compositions according to the present invention can be usedin conjunction with chemotherapy in order to relievechemotherapy-associated nausea or vomiting.

As used herein, the term “therapeutic effect against cancer” means anyeffect against cancer, including but not limited to symptomatic relief,improvement in subjective well-being, histological improvement such asreduction in tumor burden, reduction in stage or grade of the tumor,reduction of tissue damage associated with malignancy, or otherbiological, pathological, or histological effects.

In another embodiment of the composition, Soma is not used. Instead, thecompositions described above as MSQ-11, MSQ-12, or MSQ-13 areadministered. In this embodiment, the composite mixture (MSQ-11, MSQ-12or MSQ-13) is administered orally at a dose of 1-3 tbsp (15-45 ml) foradults, preferably at 2 tbsp, three times a day taken with meals. Alongwith this treatment, 6 glasses of water should be taken daily spaced atproper intervals. This administration schedule is followed for 3-4weeks. The dosage can be adjusted as needed depending on the response ofthe patient. The administration of this therapy may continue dependingon the rate of cancer regression. The therapy can be usedprophylactically after remission is obtained.

Another aspect of the present invention is a method of treating cancercomprising administering a composition or compositions according to thepresent invention to a patient in need thereof. The compositionsadministered can include Soma. Alternatively, the composition can be oneof MSQ-11, MSQ-12, or MSQ-13, without Soma. If the composition is acomposition according to the present invention including ground redpepper, corn oil, pineapple juice, and raw almonds, the methodpreferably further comprises administering aspirin to the patient.

The malignancy to be treated can be, but is not necessarily limited to,a malignancy of the lymphoid system.

The following Examples illustrate the advantages of the subjectinvention. These Examples are illustrative only and are not intended tolimit the invention. Accordingly, it is to be understood that thedescription in this disclosure is to facilitate comprehension of theinvention and should not be construed to limit the scope thereof aspersons skilled in the art can, in light of this disclosure, generateadditional embodiments without exceeding the scope or departing from thespirit of the claimed invention.

EXAMPLE 1

Resolution of Pleuritis Carcinomatosa and Atelectasis in an InoperableMalignant Lung Cancer

A 55-year-old male patient was admitted to the hospital on Oct. 27, 1999with right-sided chest pain, hemoptysis, worsening shortness of breath,and dyspnea on exertion.

He had a history of smoking for 40 years, 1.5-2 packs a day. He claimedthat he consumed 1 glass of wine and 2 bottles of beer a day. Hesuffered myocardial infarction in May 1999. On physical exam he was anobese man who appeared older than his chronological age. Chest andthroat exam revealed emphysema and severe chronic laryngitis. Cardiacenlargement and hepatomegaly was observed. Extremities were free ofedema and clubbing.

His blood gases on room air were pO₂ 61.9, pCO₂ 52.6, pH 7.39 and Sat91%. A CT of the chest revealed a large mass in the third segment of theright lung that propagated onto the pleura. Around the mass,distelectasis and infiltration was observed. Pleural fluid or abnormallymph nodes were absent.

A biopsy was performed and the initial finding was a partiallyundifferentiated squamous cell carcinoma. Due to the patientscardio-respiratory status and the extent of the infiltration, the tumorwas evaluated as inoperable. The exact size of the tumor could not bedetermined.

He was placed on a Carboplatin and Vepesid combination chemotherapy andradiation therapy. He received 2 cycles of chemotherapy and 30 Gy ofirradiation. A chest CT taken on Mar. 3, 2000 had shown the presence ofa 5 cm diameter tumor in the upper right lobe that contained anirregular internal cavity, and showed propagation onto the pleura. InApril 2000, the patient decided to discontinue the therapies due totheir severe side effects.

Starting in June 2000, the patient has taken a one month long course ofthe oral combination herbal supplement, MSQ-11. The active ingredientsare molasses, apple cider vinegar, quinine and sulfur. The dosage was3×1 tablespoons a day taken with meals until 1 quart of the mixture wasconsumed. Ample consumption of whole milk with the formula wasrecommended.

Two weeks after the initiation of MSQ-11 supplementation, hemoptysisresolved. Shortly after completing the course, pneumonia developedspecifically affecting the tumor site. Antibiotics were prescribed andthe pneumonia subsequently resolved.

After the resolution of the pneumonia, the patient enjoyed a relativelyuneventful three months before he was again admitted to the hospital onOct. 13, 2000 with right-sided anterior chest pain, shortness of breath,dyspnea on exertion and peripheral edema.

His blood gases were PO₂ 5.59 kPa, pCO₂ 7.60 kPa, pH 7.383 and Sat79.8%. A chest X-ray revealed the progression of the tumor in the upperright lobe as well as pleural fluid accumulation. Complete atelectasisof the right lung had developed. During pleurocentesis, 650 ml of fluidwas removed which contained blood, large numbers of lymphocytes,macrophages and mesothelial cells. In the cytology report, there is nomention of tumor cells. Subsequently, he was released and instructed toreturn in the event if his dyspnea was worsening.

Five weeks later on Nov. 20, 2000, the patient was readmitted to thehospital with fever (37.7-38.8° C.), shortness of breath, and dyspnea onrest. His blood gases on admission were PO₂ 43, pCO₂ 52, pH 7.43 and Sat79%. Chest x-ray revealed the progression of the upper right lobe tumorwith an expansion into the central lobe. Complete atelectasis of theright lung and hydrothorax had developed. During another pleurocentesis,800 ml of pleural fluid was removed. The pleural fluid contained largenumbers of white blood cells. The general condition of the patient didnot allow chemotherapy. At this point, the prognosis was extremelybleak.

At this time, a combination of Soma extract and MSQ-11 was given. Oneweek after his second pleural drainage, the patient started taking 1 mlof Soma extract twice a day, dissolved in a cup of water (starting onNov. 29, 2000). Soma was administered for six weeks. At three weeks intothe Soma therapy, MSQ-11 was added to the regimen at 3 tbsp per day forone month. A maintenance dose of 1 tbsp of MSQ-11 a day was used for anadditional month after completing this standard treatment course.

The patient's hypoxia was relieved with a nutritional supplement, calledAerobic 07 (Aerobic Life Industries, Phoenix, Ariz., USA). Aerobic 07delivers oxygen directly into the circulation via the stomach. Thedosage was 10 drops dispersed into a cup of water, taken twice a day,following the general recommendations of the manufacturer. The patientreported an immediate relief from his dyspnea upon taking the first doseof Aerobic 07. Four days later upon his discharge, the patient's bloodoxygen saturation was 88%.

He continued using Aerobic 07 at the same dose for 4 months and foranother 4 months at a half dose. The patient reported Aerobic 07 to bevery important in improving his general well being. Repeateddetermination of oxygen saturation has shown a continuous progress.

On Jan. 3, 2001, the patient was readmitted to the hospital, and 350 mlof yellow pleural fluid was removed. Cytology found a few lymphocytesand macrophages with no blood or tumor cells present. This time itappeared that his pleuritis carcinomatosa was subsiding. Blood gaseswere pO₂ 7.06 kPa, pCO₂ 6.40 kPa, pH 7.462 and Sat 89.1%.

One week later on Jan. 10, 2001, ahead and chest CT was performed. Noabnormalities were found inside the cranium. Abnormal lymph nodes wereabsent in the mediastinum. A circular constriction of the upper rightlobar bronchus was observed. In the upper right lobe, tumorousinfiltration was apparent. The size of the upper right lobe tumor couldnot be determined. The image suggested necrosis. Pleural fluidaccumulation was noted but it was insufficient for tapping. He wasreleased from the hospital.

From January the patient lived at home and reported a relatively goodquality of life. On Mar. 26, 2001, the patient checked into the hospitalbecause of chest pain. His blood gases-were pO₂ 8.73 kPa, pCO₂ 5.89 kPa,pH 7.421 and Sat 93.1%. The patients blood oxygen saturation hadreturned to normal. Chest x-ray found no tumor progression and pleuralfluid was undetectable. The episode was diagnosed as viral infection.

Four months later, he was admitted to the hospital again because ofright-sided chest pain. Chest x-ray has shown no change since hisprevious admission. An ultrasound exam found no abnormalities in theorgans inside the abdomen. Results of any cardiac evaluation could notbe found. The chest pain was attributed to scar tissue formation in theupper right lobe. He was given pain medication and released.

A month later, the patient was admitted to the hospital, this time withworsening signs of congestive heart failure. At the same time, chestx-ray showed progression of the upper right lobe tumor. Pleural fluidwas undetectable. MSQ-11 administration was initiated. His cardiacfunctions continued to deteriorate and were not responding to therapy.Three weeks later, he deceased. At the family's request, no autopsy wasperformed.

Discussion

Lung cancer can be linked to tobacco smoking in the majority of cases(Doll, R, Gray R, Hafner B, and Peto R. Br Med J 280: 961-971, 1980;Doll R and Hill A. Br Med J 2: 1071-108 1, 1956). Despite the greatexpansion of understanding cancer biology, lung cancer remains one ofthe deadliest human neoplasias. About 90% of lung cancer patients diedue to the worst cure rates among common solid tumors (“Cancer Facts andFigures2000.” 2000 American Cancer Society, Atlanta). New therapeuticstrategies are therefore needed that can improve current prospects forlong-term survival from lung cancer.

In this Example, we presented a patient's case with rapidly progressing,large, partially undifferentiated squamous cell carcinoma (Marchevsky AM. Malignant epithelial tumors of the lung. In: Marchevsky A M, ed.Surgical pathology of lung neoplasms. N.Y., Marcel Dekker, 1990:77-229)and demonstrated the resolution of carcinomatous pleuritis andatelectasis developed during the progression of his carcinoma. Thepatient had a history of emphysema and acute myocardial infarction. Hiscritical condition and the bleak prognosis of his disease qualified himfor this alternative approach.

The progression of the tumor discontinued and the pleuritiscarcinomatosa resolved over a period of 2 months while using acombination of Soma and MSQ-11. The patient reported a gradual increasein his energy and an overall improvement in the quality of his life thatlasted for nearly 8 months. He experienced no side effects during Somaand MSQ-11 administration. Additional oral oxygenation was effective inrelieving the patients dyspnea and improved oxygenation may havecontributed to the overall effects of Soma and MSQ-11.

This study described how the administration of a combination of naturalremedies coincided with the regression of an originally inoperable lungcarcinoma. We believe that this therapeutic modality will have a similarbeneficial effect for all cancers including carcinomas, sarcomas andlymphomas.

EXAMPLE 2

Tumor Regression in a Recurrent, Metastatic Squamous Cell Carcinoma ofthe Cervix: Case Report

Cervical carcinoma is a common gynecological neoplasia that caused 4,100deaths in 2002 in the United States (1). Radical pelvic surgery andradiation therapy is the mainstay in treatment (2). Chemotherapy isgenerally reserved for treatment of locally recurrent disease (3,4).Despite advances in surgical techniques, radiation, and chemotherapy,stage-specific survival rates of patients with locally advanced cervicalcancer have not improved (2,5). Therefore, it is important to developnew treatment modalities in order to improve current prospects forlong-term survival.

In this report, a patient's case is presented with a recurrent,metastatic squamous cell carcinoma of the cervix. The reportdemonstrates that a novel, nutritional combination therapy producedtumor regression and no evidence of disease.

Methods

In June 1998, a 43 year-old patient was diagnosed with squamous cellcarcinoma of the cervix (grade II/A) and metastasis to the colon. Sheunderwent Wertheim's radical hysterectomy and pre- and post-operativeradiation therapy for a total dose of 50 Gy.

In June 2000, she was diagnosed with right-sided hydronephrosis,rectovaginal fistula, and recurrent malignant disease in the pelvis.Rectovaginal exam confirmed a 6-cm tumor that was partially attached tothe pelvic wall and infiltrated the base of the bladder as well as thecolon. In July 2000, 6 cycles of the Cysplatin-Vepesid-Epirubicincombination chemotherapy was initiated. She received 2 cycles ofchemotherapy (one each in July and August). Because of the serious sideeffects of the treatment (myelosuppression, nausea, vomiting and severepain in the flanks and extremities) no further chemotherapy wasadministered and the patient received only red blood cell transfusionsand pain medication from that on. Her prognosis was poor.

Starting in the beginning of November 2000, the patient has taken a onemonth long course of MSQ-11. This formula was established based on theanalysis of the scientific literature on the effects of nutrition on avariety of cancers (6). The active ingredients are blackstrap molasses,apple cider vinegar, quinine and sulfur. The dosage was 1 tbsp TID potaken with meals until 1 quart (946 ml) of the mixture was consumed,then 1 tbsp QD for another 5 months. Ample consumption of whole milk orpurified water with the formula is recommended.

Besides MSQ-11, Soma a healing herb described in the sacred scripturesof the Hindis, the Rig Veda (7) was also administered. Soma is creditedwith healing powers in a variety of diseases. Soma extract was preparedfollowing the directions in the 9th Book of Rig Veda.

The dosage for Soma was 1 ml of extract QD po, taken in a cup of waterand administered for 4 weeks. Subsequently, it was taken every otherday. Shortly after starting on these nutritional supplements, thepatient reported an improvement in her appetite and general well being.She started gaining weight. The clinical manifestations of neuropathyhave subsided and the myelosuppression, as evidenced by normal CBC,disappeared. Her other blood test results normalized and rectovaginalexams demonstrated the regression of the tumor. The patient wasmonitored periodically by clinical examinations and by May 2001 no tumorcould be detected clinically or otherwise. In September 2001, thepatient underwent an ileus surgery and the preparation of a temporarypreternatural anus.

The patient remained stable until January 2002, when she presented withhigh fever and right flank pain. This was attributed to a urinaryinfection caused by the yet unresolved rectovaginal fistula. Abdominalultrasound exam has shown a right-sided renal abscess, the resolution ofwhich required right-sided nephrectomy. In March 2002, an abdominal CTexam has shown an irregularly shaped growth in the right side of thepelvis that has accumulated contrast material and was in contact withthe base of the bladder as well as the adjacent intestines.

A gynecological exam in April 2002 has found a mass around the vaginalcuff that filled the entire pelvis area and was suspected to be arecurrent tumor. Pathological exam has shown the recurrence of SCC ofthe cervix (grade III-IV). The tumor was evaluated to be inoperable. Inthe same month, the surgical repair of the rectovaginal fistula wascarried out. At this point, she has resumed taking MSQ-11 and Soma. Somawas administered at the same dosage as in 2001 while the dosage ofMSQ-11 was 2 tbsp TID. The tumor regression was monitored by pelvicultrasound, and clinical examinations. Subsequently, the nutritionalsupplement regime was adapted according to the clinical status andultrasound results.

In May 2002, an ultrasound exam has shown a highly vascularized,41×53×60 mm size tumor in the right side of the pelvis that hasinfiltrated the wall of the bladder. Thus, a more active formula,MSQ-11A that also contained vitamin B₁₂ and rose oil was administeredinstead of MSQ-11 at 2 tbsp TID. The use of Soma was discontinued.

In June 2002, an ultrasound exam has shown a 40×27×28 mm size tumor inthe right side of the pelvis that was attached to the bladder over anarea of 2 cm diameter and to the colon over an area of 1.7 cm diameter.A subsequent CT exam has shown the adhesion of intestinal loops to thebase and the right side of the bladder. Inside the conglomerate, a 3 cmdiameter solid formation was found that was thought to be the tumor.

An ultrasound exam in July 2002, has demonstrated a 30×33×60 mm sizeirregular-shaped formation in the right side of the pelvis. Topotentially accelerate tumor regression, MSQ-11A was replaced with themore active MSQ-13 formula. MSQ-13 contains folic acid and moleculariodine as additional components. After completing the basic course ofMSQ-13 therapy (2 quarts), a pelvic hemorrhagic episode occurred. Largeblood clots were spontaneously discharged rectally and vaginally. Thesurgical team interpreted this as possible healing process. The anemiacaused by the hemorrhage resolved without a need for intervention. Thepatient continued with the nutritional supplementation. Subsequentultrasound exam has found an 8×5 cm formation in the right side of thepelvis. The enlargement was probably caused by the hemorrhage.

A CT exam in late September 2000 has found an irregular-shaped softtissue conglomerate in the right side of the pelvis that was attached tothe right side of the bladder. Above the vaginal fornix, a 4-5 cm-sizesolid formation was found. The oral contrast material accumulated insidethe vagina (vaginal tampon) indicating the presence of a still existingfistula. No accumulation of contrast material was observed elsewhere.Abnormal lymph nodes were absent in the retroperitoneum. An MRI exam wasprescribed to differentiate the tumor from the surrounding scar tissue.

Subsequent to the hemorrhage, the patient noticed a graduallyintensifying inflammation in her pelvis by early October 2002. Onmultiple occasions, spontaneous putrid smelling vaginal and rectaldischarges occurred that were accompanied with episodes of fever (37-38°C.). After a gynecological exam and a CT scan in November 2002, she wasreferred to emergency surgery during which an about 12 cm size abscesswas drained in the lower abdomen. The examination of the surroundingarea indicated a potential continuation of the abscess. A lower pelviclaparotomy was performed that opened another, larger abscess thatstretched from behind the symphysis towards the vaginal cuff. Followingthe lysis of small bowel adhesions, an encapsulated 3.5×5 cm size tumor,extensively attached to the sacrum, was observed. No metastases werefound in the abdominal cavity.

The small bowel fistula could not be repaired at this time and thepatient was scheduled for another surgery in February 2003. The fistularepair was attempted at the end of February 2003; however it turned outto be unsuccessful. Another surgery was performed in the middle of April2003 to close the fistula but, again, it was unsuccessful. The patientdeceased at the end of April 2003. No autopsy was performed at thefamily's request.

Discussion

Survival for woman with cervical cancer has improved over the yearsprimarily because of early diagnosis. For advanced disease, the 5-yearsurvival rates remain unchanged (2,5). The 31% survival for stage IIIand 8% for stage IVA disease indicates that radiotherapy is not aneffective therapeutic modality. Chemotherapy has been used for themanagement of locally recurrent disease but objective and subjectiveresponses are of short duration (4,5). The prognosis for recurrent,locally advanced cervical carcinoma is poor.

This case study demonstrates that a combination of nutritionalsupplements may offer an effective tool for the management of recurrentSCC of the cervix. This patient's critical condition and her poorprognosis qualified her for this alternative approach.

This paper describes a non-toxic, nutritional therapy that wasestablished based on the analysis of the scientific literature on theeffects of nutrition on a variety of cancers (6). This analysis led tothe conclusion that nutrition can provide a unifying perception ofcancer and recast it as a single disease potentially treatable by asingle protocol.

Nutritional deficiencies of plant-derived phenolic compounds, lipids,vitamins and minerals have been identified in a variety of cancers (6).Based on these, it was hypothesized that the supplementation of thesenutrients of adequate amounts to cancer patients might reverse thecourse of the disease as human cells do have the capacity ofself-repair.

During the first recurrence of the disease, a combination of Soma andMSQ-11 was administered at a low dosage over a time period of severalmonths. This cautious dosage regimen was warranted by the fact that shehad come out of chemotherapy with right-sided renal failure,myelosuppressed and neuropathic. Her general condition was very weak inthe beginning of nutritional supplementation. Shortly after theinitiation of supplementation, her appetite returned and over a timeperiod of 2 months, she has regained all her lost weight.Myelosuppression and neuropathy have resolved. Her general conditionimproved such that she has resumed her daily routines. Clinical dataconfirmed tumor regression and subsequently has shown no evidence ofdisease. She has experienced no side effects during administration ofnutritional supplementation.

The unresolved rectovaginal fistula, a frequent combined side effect ofdisease and intensive pelvic radiation therapy, led to seriouscomplications. A renal abscess developed, the resolution of whichrequired right-sided nephrectomy. A satisfactory recovery allowed thesubsequent repair of the rectovaginal fistula. Pathological examconfirmed a recurrence of SCC of the cervix, which this time hasinfiltrated the colon and the bladder.

The patient has resumed taking Soma and MSQ-11 that later on wasreplaced with the more active MSQ-11A and MSQ-13. Tumor regression ofgreater than 50% and the resolution of metastases were observed duringthe course of her second alternative treatment. Her general conditionwas fair. The patient has undergone three surgeries in 2002 and two morein 2003 in an attempt to repair the active fistulas. Unfortunately, theconditions of her bowels have made the repair attempts unsuccessful andthe patient deceased despite all the improvements in her oncologicalstatus.

Further studies are warranted to investigate the utility of thisnutritional approach in a larger population of cervical cancer patients.

REFERENCES

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3. DeVita V T, Wasserman T H, Young R C: Perspectives in research ingynecologic oncology. Cancer 38; 509-525, 1991.

4. Alberts D S, Garcia D, Mason-Liddil N: Cysplatin in advanced cancerof the cervix: An update. Semin Oncol 18; 11-24, 1991.

5. Petterson F (ed.): Carcinoma of the uterine cervix. In: Annual reporton the results of treatment in gynecological cancer. FIGO 22; 51-63,1994.

6. Grandics P: submitted for publication.

7. Griffith R T H: The hymns of the Rigveda, Shastri, J L ed. Delhi,Motilal Banarsidass Publishers, 1999.

While the specification describes particular embodiments of the presentinvention, those of ordinary skill can devise variations of the presentinvention without departing from the inventive concept.

1. A therapeutic composition for the treatment of cancer comprising: (a)an aqueous extract of the plant Soma, the plant Soma being identified asAsclepias tuberosa, the aqueous extract being preserved with salt; and(b) a mixture of milk, plant derivatives and a mineral comprising: (i)apple cider vinegar; (ii) quinine; (iii) blackstrap molasses; (iv)sulfur; and (v) whole milk; wherein the aqueous extract of Soma, theapple cider vinegar, the quinine, the blackstrap molasses, and thesulfur are each present in a sufficient quantity so that the resultingcomposition has a therapeutic effect against cancer.
 2. The compositionof claim 1 wherein the composition further comprises ground red pepper,corn oil, pineapple juice, and raw almonds.
 3. The composition of claim1 wherein the composition further comprises iodine.
 4. The compositionof claim 1 wherein the composition further comprises Vitamin B₁₂ androse petal extract/rose oil.
 5. The composition of claim 4 wherein thecomposition further comprises folic acid.
 6. The composition of claim 1wherein the mixture of plant derivatives and a mineral comprises about6.23% (v/v) of apple cider vinegar, about 0.317% (w/v) of quinine, about79.8% (v/v) of blackstrap molasses, and about 3.1% (w/v) of sulfur. 7.The composition of claim 1 wherein the aqueous extract of the plant Somais prepared from roots of the plant Soma that had been steeped inboiling water for about 20 minutes to inactivate potentially toxicproteins.
 8. A therapeutic composition for the treatment of cancercomprising: (a) an aqueous extract of the plant Soma, the plant Somabeing identified as Asclepias tuberosa, the aqueous extract beingpreserved with salt; and (b) a mixture of water, plant derivatives and amineral comprising: (i) apple cider vinegar; (ii) quinine; (iii)blackstrap molasses; (iv) sulfur; and (v) water; wherein the aqueousextract of Soma, the apple cider vinegar, the quinine, the blackstrapmolasses, and the sulfur are each present in a sufficient quantity sothat the resulting composition has a therapeutic effect against cancer.9. The therapeutic composition of claim 8 wherein the aqueous extract ofthe plant Soma is prepared from roots of the plant Soma that had beensteeped in boiling water for about 20 minutes to inactivate potentiallytoxic proteins.
 10. A method for treatment of cancer comprisingadministering an effective amount of the composition of claim 1 to apatient in need of treatment thereof.
 11. A method for treatment ofcancer comprising administering: (a) an effective amount of thecomposition of claim 2; and (b) aspirin, to a patient in need oftreatment thereof.
 12. A method for treatment of cancer comprisingadministering an effective amount of the composition of claim 3 to apatient in need of treatment thereof.
 13. A method for the treatment ofcancer comprising administering an effective amount of the compositionof claim 4 to a patient in need of treatment thereof.
 14. A method forthe treatment of cancer comprising administering an effective amount ofthe composition of claim 5 to a patient in need of treatment thereof.15. A method for the treatment of cancer comprising administering aneffective amount of the composition of claim 6 to a patient in need oftreatment thereof.
 16. A method for the treatment of cancer comprisingadministering an effective amount of the composition of claim 7 to apatient in need of treatment thereof.
 17. A method for the treatment ofcancer comprising administering an effective amount of the compositionof claim 8 to a patient in need of treatment thereof.
 18. A method forthe treatment of cancer comprising administering an effective amount ofthe composition of claim 9 to a patient in need of treatment thereof.19. The method of claim 10 wherein the cancer is a malignancy of thelymphoid system.
 20. The method of claim 11 wherein the cancer is amalignancy of the lymphoid system.
 21. The method of claim 12 whereinthe cancer is a malignancy of the lymphoid system.
 22. The method ofclaim 13 wherein the cancer is a malignancy of the lymphoid system. 23.The method of claim 14 wherein the cancer is a malignancy of thelymphoid system.
 24. The method of claim 16 wherein the cancer is amalignancy of the lymphoid system.
 25. The method of claim 17 whereinthe cancer is a malignancy of the lymphoid system.
 26. The method ofclaim 18 wherein the cancer is a malignancy of the lymphoid system. 27.The method of claim 10 wherein the composition is used in conjunctionwith chemotherapy and relieves chemotherapy-associated nausea orvomiting.
 28. The method of claim 11 wherein the composition is used inconjunction with chemotherapy and relieves chemotherapy-associatednausea or vomiting.
 29. The method of claim 12 wherein the compositionis used in conjunction with chemotherapy and relieveschemotherapy-associated nausea or vomiting.
 30. The method of claim 13wherein the composition is used in conjunction with chemotherapy andrelieves chemotherapy-associated nausea or vomiting.
 31. The method ofclaim 14 wherein the composition is used in conjunction withchemotherapy and relieves chemotherapy-associated nausea or vomiting.32. The method of claim 16 wherein the composition is used inconjunction with chemotherapy and relieves chemotherapy-associatednausea or vomiting.
 33. The method of claim 17 wherein the compositionis used in conjunction with chemotherapy and relieveschemotherapy-associated nausea or vomiting.
 34. The method of claim 18wherein the composition is used in conjunction with chemotherapy andrelieves chemotherapy-associated nausea or vomiting.